Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetic Neuropathy, Neurology, Gastrointestinal, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | June 2013 |
| End Date: | December 2016 |
| Contact: | Stephen Barrett, DPM |
| Email: | slbarrettpod@me.com |
| Phone: | 623 572-3456 |
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic
foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve
pinching and entrapment. Historical risk of 25% annually has been reported to decrease by
>80% to under 5% yearly. Since an open wound precedes the large majority (85%) of
amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the
current academic opinion that nerve decompression will not decrease ulcer recurrence risk.
Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve
pinching and entrapment. Historical risk of 25% annually has been reported to decrease by
>80% to under 5% yearly. Since an open wound precedes the large majority (85%) of
amputations in diabetes, avoidance of ulcer recurrences is important. This study tests the
current academic opinion that nerve decompression will not decrease ulcer recurrence risk.
Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
Diabetes patients with a recently healed, non-ischemic plantar diabetic foot ulcer will be
randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve
decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot.
Comparison of the control group with standard care to the surgical intervention group will
be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be
calculated. Additional subjective and objective secondary outcomes will be monitored. Null
hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
If protection against ulcer occurrence were to be confirmed, a change in the treatment
paradigm for diabetic neuropathy and foot ulcer could be appropriate.
randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve
decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot.
Comparison of the control group with standard care to the surgical intervention group will
be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be
calculated. Additional subjective and objective secondary outcomes will be monitored. Null
hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
If protection against ulcer occurrence were to be confirmed, a change in the treatment
paradigm for diabetic neuropathy and foot ulcer could be appropriate.
Inclusion Criteria:
- Type 1 or Type 2 Diabetes Mellitus
- Diabetic sensorimotor peripheral neuropathy
- Recently healed plantar neuropathic Diabetic Foot Ulcer (< 18 months)
- At least one palpable foot or ankle pulse or ABI>0.8 bilaterally.
- Recent Hgb A1c < 9.0%
- Ankle edema absent or mild
Exclusion Criteria:
- Ischemic peripheral vascular disease or ankle-brachial index (ABI)<0.8
- History of peripheral vascular arterial surgery
- History of peripheral nerve or lumbar disc surgery
- alcohol abuse(more than 2 drinks/day)
- untreated thyroid disorders
- B12 or Folate deficiency
- spondyloarthropathies
- hepatic disease
- advanced renal disease
- current lumbosacral radiculopathy or nerve compression
- toxin exposure including chemotherapeutic agents
We found this trial at
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